(45 days)
Tufflex™ Polyester Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Tufflex™ polyester suture is a nonabsorbable, braided, sterile, surgical suture composed of poly(ethylene terephthalate co-isophthalate). It is prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component. Tufflex™ sutures are braided for optimal handling properties.
The provided text describes the 510(k) submission for the Tufflex™ polyester suture, which is a medical device. The information primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving the device meets acceptance criteria through a traditional clinical study with detailed performance metrics like those for diagnostic AI devices.
Instead of "acceptance criteria," the document refers to compliance with USP requirements and equivalence to predicate materials for specific physical properties of the suture.
Here's an analysis based on the provided text, structured to answer your questions where applicable. Please note that many of your specific questions are designed for AI/diagnostic device studies and are not directly addressed by this type of 510(k) for a physical medical product like a suture.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Property) | Reported Device Performance (Tufflex™ Polyester Suture) |
|---|---|
| Suture Diameter (USP Requirements) | Satisfied USP requirements and was equivalent to predicate materials. |
| Knot Tensile Strength (USP Requirements) | Satisfied USP requirements and was equivalent to predicate materials. |
| Sterilization Process Equivalence | Equivalent to the process used by predicate suture manufacturers. |
2. Sample Size Used for the Test Set and Data Provenance
The text does not specify the exact sample sizes used for testing suture diameter or knot tensile strength. It only states that "summaries of studies were conducted to evaluate the suture diameter and knot tensile strength as specified in the FDA Guidance Document."
- Data Provenance: Not explicitly stated, but typical for physical medical device testing, it would likely be laboratory-generated data from manufacturing lots. There is no mention of country of origin of data, nor whether it was retrospective or prospective in the clinical sense (as it's a materials test, not a patient outcome study).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this type of device. "Ground truth" in the context of a physical medical device like a suture refers to established physical standards (USP requirements). No human experts are used to "establish" this ground truth in the way described for AI/diagnostic devices. The testing is objective against published standards.
4. Adjudication Method for the Test Set
Not applicable. There is no ambiguous "result" that requires adjudication by experts, as the testing is against defined physical parameters.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study is for evaluating observer performance with diagnostic or AI-assisted interpretation, which is not relevant for a surgical suture.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI or algorithm-based device. The "performance" is based on the physical properties of the suture itself.
7. The Type of Ground Truth Used
The ground truth used for evaluating the Tufflex™ polyester suture's performance against the "acceptance criteria" (USP requirements) is objective physical standards and specifications for surgical sutures. It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of the Study and Acceptance Criteria:
The "study" cited in the 510(k) submission for the Tufflex™ polyester suture was a series of tests performed to demonstrate that the device complies with the United States Pharmacopeia (USP) requirements and is equivalent to predicate devices for key physical properties.
- Acceptance Criteria: Compliance with USP requirements for suture diameter and knot tensile strength, and equivalence to the sterilization process of predicate devices. These criteria are established by regulatory guidance ("Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" - June 23, 2003) and industry standards (USP).
- Study That Proves Meets Criteria: The manufacturer "conducted summaries of studies" to evaluate these properties. The data from these studies "demonstrate that the Tufflex™ polyester suture satisfied the USP requirements and was equivalent to the predicate materials."
In essence, for this type of medical device, "acceptance criteria" are met by demonstrating adherence to established material specifications and manufacturing equivalency, rather than through clinical performance studies involving patient outcomes or expert interpretation.
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K063194 1/2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)
General Company Information
| Name: | Axya Medical, Inc. | DEC - 4 2006 |
|---|---|---|
| Contact: | Howard SchrayerRegulatory Affairs Consultant | |
| Address: | 100 Cummings CenterSuite 444CBeverly, MA 01915 | |
| Telephone: | (978) 232 - 9997 | |
| Fax: | (978) 232 - 9998 | |
| Date Prepared | October 18, 2006 | |
| General Device Information |
- Product Name: Tufflex™ polyester suture
Classification: "Nonabsorbable poly(ethylene terephthalate) surgical suture" Product code: GAT - Class II 21 CFR 878.5000
Predicate Devices
Axya Medical, Inc. AxyaFlex™ Polyester Suture [510(k) Number K060165]
Smith & Nephew DuraBraid™ Polyester Suture [510(k) Number K040789]
Description
Tufflex™ polyester suture is a nonabsorbable, braided, sterile, surgical suture composed of poly(ethylene terephthalate co-isophthalate). It is prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component. Tufflex™ sutures are braided for optimal handling properties.
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063194 2/2
Intended Use (Indications)
Tufflex™ suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Substantial Equivalence
This submission supports the position that the Tufflex™ polyester suture is substantially equivalent to a number of previously cleared devices, including the Axya Medical, Inc. AxyaFlex™ polyester suture and the Smith & Nephew DuraBraid™ Polyester Suture.
The 510(k) Notice contains summaries of studies that were conducted to evaluate the suture diameter and knot tensile strength as specified in the FDA Guidance Document entitled "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" (June 23, 2003).
The data presented demonstrate that the Tufflex™ polyester suture satisfied the USP requirements and was equivalent to the predicate materials.
The sutures are provided sterile. The suture material is sterilized using a process equivalent to the process used by the predicate suture manufacturers.
Conclusions
Axya Medical, Inc. believes that the information provided establishes that similar legally marketed sutures have been used for the same clinical applications for the Tufflex™ polyester suture. The material from which the Axya suture is fabricated and the suture coating have an established history of use in medical applications; and devices produced by Axya have been tested in accordance with applicable FDA guidelines.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Axya Medical, Inc. % Mr. Howard L. Schrayer 100 Cummings Center, Suite 444C Beverly, Massachusetts 01915
DEC - 4 2006
Re: K063194
Trade/Device Name: Tufflex™ Polyester Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulation Class: II Product Code: GAT Dated: November 6, 2006 Received: November 8, 2006
Dear Mr. Schrayer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Howard L. Schrayer
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for Phil
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Kob3194 1/1
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Tufflex™ Polyester Suture
Indications For Use:
Tufflex™ Polyester Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pedro Muniz
(Division Sign-C Division of General, Restorative, and Neurological L
510(k) Number L 063194
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.